Abstract：
OBJECTIVE: To compare the efficacy of transarterial chemoembolization (TACE) combined with tyrosine kinase inhibitors (TKIs) plus immune checkpoint inhibitors (ICIs) (TACE-TKI-ICI) versus TKIs plus ICIs (TKI-ICI) for unresectable hepatocellular carcinoma (HCC) with first- or lower-order portal vein tumor thrombosis (PVTT).
METHODS: A retrospective study was performed in HCC patients with first- or lower-order PVTT receiving TKIs (Lenvatinib or sorafenib) plus ICIs (camrelizumab, sintilimab, or atezolizumab) with or without TACE from four institutions between January 2019 and January 2022. Propensity score-based method was performed to minimize bias by confounding factors. Tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated and compared between the two groups.
RESULTS: After inverse probability of treatment weighting, two balanced pseudopopulations were created: 106 patients in the TACE-TKI-ICI group and 109 patients in the TKI-ICI group. The objective response rate was higher in the TACE-TKI-ICI group (50.9% vs. 28.4%, P < 0.001). The median PFS and OS were significantly longer in the TACE-TKI-ICI group than in the TKI-ICI group (PFS: 9.1 vs. 5.0 months, P = 0.005; OS: 19.1 vs. 12.7 months, P = 0.002). In Cox regression, TACE-TKI-ICI treatment was an independent predictor of favorable OS. Treatment-related grade 3/4 AEs were comparable between the two groups (22.6% vs. 17.9%, P = 0.437).
CONCLUSIONS: TACE-TKI-ICI therapy contributed to better tumor control, PFS and OS than TKI-ICI therapy in unresectable HCC patients with first- or lower-order PVTT.
METHODS: A retrospective study was performed in HCC patients with first- or lower-order PVTT receiving TKIs (Lenvatinib or sorafenib) plus ICIs (camrelizumab, sintilimab, or atezolizumab) with or without TACE from four institutions between January 2019 and January 2022. Propensity score-based method was performed to minimize bias by confounding factors. Tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated and compared between the two groups.
RESULTS: After inverse probability of treatment weighting, two balanced pseudopopulations were created: 106 patients in the TACE-TKI-ICI group and 109 patients in the TKI-ICI group. The objective response rate was higher in the TACE-TKI-ICI group (50.9% vs. 28.4%, P < 0.001). The median PFS and OS were significantly longer in the TACE-TKI-ICI group than in the TKI-ICI group (PFS: 9.1 vs. 5.0 months, P = 0.005; OS: 19.1 vs. 12.7 months, P = 0.002). In Cox regression, TACE-TKI-ICI treatment was an independent predictor of favorable OS. Treatment-related grade 3/4 AEs were comparable between the two groups (22.6% vs. 17.9%, P = 0.437).
CONCLUSIONS: TACE-TKI-ICI therapy contributed to better tumor control, PFS and OS than TKI-ICI therapy in unresectable HCC patients with first- or lower-order PVTT.
摘要：
目的：比较经动脉化疗栓塞（TACE）联合酪氨酸激酶抑制剂（TKIs）加免疫检查点抑制剂（ICIs）（TACE-TKI-ICI）与TKIs加ICIs（TKI-ICI）治疗不可切除肝细胞癌（HCC）合并一级或低级门静脉肿瘤血栓形成（PVTT）的疗效。
方法：在接受TKIs（Lenvatinib或索拉菲尼）加ICIs（camrelizumab，sintilmab,或阿妥珠单抗）在2019年1月至2022年1月期间，有或没有来自四家机构的TACE。采用基于倾向得分的方法，通过混杂因素将偏倚降至最低。肿瘤反应，无进展生存期（PFS），总生存期（OS），评估并比较两组患者的不良事件(AE)。
结果：在治疗加权的逆概率之后，我们创建了两个平衡的假人群:TACE-TKI-ICI组106例患者和TKI-ICI组109例患者.TACE-TKI-ICI组的客观反应率更高（50.9%vs.28.4%,P<0.001)。TACE-TKI-ICI组的中位PFS和OS明显长于TKI-ICI组（PFS：9.1vs.5.0个月,P=0.005；OS：19.1vs.12.7个月,P=0.002)。在Cox回归中，TACE-TKI-ICI治疗是良好OS的独立预测因子。治疗相关的3/4级不良事件在两组之间具有可比性（22.6%vs.17.9%,P=0.437）。
结论：TACE-TKI-ICI治疗有助于更好地控制肿瘤，PFS和OS比TKI-ICI治疗不可切除的HCC患者的一级或低阶PVTT。
方法：在接受TKIs（Lenvatinib或索拉菲尼）加ICIs（camrelizumab，sintilmab,或阿妥珠单抗）在2019年1月至2022年1月期间，有或没有来自四家机构的TACE。采用基于倾向得分的方法，通过混杂因素将偏倚降至最低。肿瘤反应，无进展生存期（PFS），总生存期（OS），评估并比较两组患者的不良事件(AE)。
结果：在治疗加权的逆概率之后，我们创建了两个平衡的假人群:TACE-TKI-ICI组106例患者和TKI-ICI组109例患者.TACE-TKI-ICI组的客观反应率更高（50.9%vs.28.4%,P<0.001)。TACE-TKI-ICI组的中位PFS和OS明显长于TKI-ICI组（PFS：9.1vs.5.0个月,P=0.005；OS：19.1vs.12.7个月,P=0.002)。在Cox回归中，TACE-TKI-ICI治疗是良好OS的独立预测因子。治疗相关的3/4级不良事件在两组之间具有可比性（22.6%vs.17.9%,P=0.437）。
结论：TACE-TKI-ICI治疗有助于更好地控制肿瘤，PFS和OS比TKI-ICI治疗不可切除的HCC患者的一级或低阶PVTT。
